M2A Magnum HIP System
17 catalogue numbers from US157846, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented. 14 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (2). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | LPH |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| 510(k) | K101336 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2015-10-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| US157846 | 46MM OUTER Ø 40MM INNER Ø | In distribution |
| US257866 | 66MM OUTER Ø 60MM INNER Ø | In distribution |
| US257848 | 48MM OUTER Ø 42MM INNER Ø | In distribution |
| US157846 | 46MM OUTER Ø 40MM INNER Ø | In distribution |
| US257844 | 44MM OUTER Ø 38MM INNER Ø | In distribution |
| US257854 | 54MM OUTER Ø 48MM INNER Ø | In distribution |
| US157850 | 50MM OUTER Ø 44MM INNER Ø | In distribution |
| US157858 | 58MM OUTER Ø 52MM INNER Ø | In distribution |
| US257862 | 62MM OUTER Ø 56MM INNER Ø | In distribution |
| US257858 | 58MM OUTER Ø 52MM INNER Ø | In distribution |
| US257848 | 48MM OUTER Ø 42MM INNER Ø | In distribution |
| US257860 | 60MM OUTER Ø 54MM INNER Ø | In distribution |
| 139268 | 52-60MM HEAD SIZE Ø TYPE I TAPER | Withdrawn |
| 139258 | 42-50MM HEAD SIZE Ø TYPE I TAPER | Withdrawn |
| 139254 | 42-50MM HEAD SIZE Ø TYPE I TAPER | Withdrawn |
| 139266 | 52-60MM HEAD SIZE Ø TYPE I TAPER | Withdrawn |
| 139274 | 52-60MM HEAD SIZE Ø TYPE I TAPER | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Initia Total Hip System | Kyocera Medical Technologies, Inc. | 1,000 |
| DJO Surgical | Encore Medical, L.P. | 624 |
| Pinnacle | Depuy Orthopaedics, Inc. | 613 |
| Trilogy® Longevity® | Zimmer, Inc. | 564 |
| Instrument | Howmedica Osteonics Corp | 369 |
| InSitu Hip System | Nextstep Arthropedix | 368 |
| Trilogy® | Zimmer, Inc. | 359 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 298 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Zimmer, Inc. | 286 |
| Bencox Hip System | Corentec Co., Ltd. | 286 |
| OrthoMedFlex | Orthomedflex LLC | 257 |
| Sterizo Total Hip System | CPM Medical Consultants, LLC. | 240 |
Showing 12 of 792. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K030048 | 2003-02-05 |
| K023357 | 2002-11-06 |
| K022463 | 2002-08-16 |
| K001660 | 2000-06-14 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2013-04-26 | Class II | Labeling mix-ups | Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrec | 8 units | 2013-08-29 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P880025 | 1991-12-04 | AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS | Depuy Intl., Ltd. |
| P880076 | 1991-06-17 | WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS | Dow Corning Wright |
| P850061 | 1991-03-08 | BIAS(R) FIBER METAL TOTAL HIP SYSTEM | Zimmer, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.